On June 23, 2023 Calidi Biotherapeutics, Inc. ("Calidi"), a clinical-stage biotechnology company that is pioneering the development of allogeneic cell-based delivery of oncolytic viruses, reported the commitment of $25 million in Series B funding led by Jackson Investment Group ("JIG"), who has funded an initial investment of $5 million, and participation from Calidi Cure, LLC, a consortium of new and existing investors led by Allan Camaisa, CEO and Chairman of Calidi (Press release, Calidi Biotherapeutics, JUN 23, 2023, View Source [SID1234632872]). The remaining commitment is conditioned upon the consummation of the previously announced business combination between First Light Acquisition Group (NYSEAMERICAN: FLAG) and Calidi. FLAG’s Sponsor and Metric Finance Holdings will contribute sponsor economics to the Series B investors as part of the transaction. The financing will enable Calidi to continue the advancement of its pipeline including CLD-101, CLD-201, and CLD-202, which utilize a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Calidi’s technology utilizing stem cells to deliver and potentiate oncolytic viruses is a novel and differentiated approach to fighting cancer. I am grateful to our new and existing investors for their support of our mission and look forward to using this funding to continue pushing the frontiers of stem cells and oncolytic viral therapies and making a difference in the lives of patients," said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics.

"Jackson Investment Group invests in companies and people who we believe have the potential to make significant impacts in areas of great unmet need," said Rick Jackson, Chief Executive Officer of Jackson Investment Group. "We believe in the promise of Calidi’s cell-based delivery platform and are excited to support the company through this next chapter in their continued pursuit of improving outcomes for patients living with cancer." JIG, an existing investor in FLAG, is an Atlanta-based private investment firm with over $3 billion of assets under management and businesses in the energy, healthcare, real estate, technology, and bioscience industries.

Brookline Capital Markets, a division of Arcadia Securities LLC, acted as the placement agent for the transaction.

On June 23, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the appointment of Alethia Young as its new Chief Financial Officer, effective July 17th (Press release, Bicycle Therapeutics, JUN 23, 2023, View Source [SID1234632871]). Ms. Young joins Bicycle from Graphite Bio, where she served as Chief Financial Officer, and previously served as senior biotech analyst and head of research at Cantor Fitzgerald.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to welcome Alethia to Bicycle and believe her experience and insights will make her an invaluable addition to our team," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "Alethia is a seasoned expert in the biopharma industry, with her leadership position at Graphite and decade-plus of experience as a top biotech research analyst making her the ideal appointment as we continue to advance our clinical trials, prepare for commercialisation and head into our next phase of growth as a company."

Ms. Young commented, "I have been following the Bicycle story since covering them as a research analyst on the sell-side, and have been especially impressed by the recent clinical progress the team has made across their platform, from the Bicycle toxin conjugate (BTC) and Bicycle tumor-targeted immune cell agonist (Bicycle TICA) programs, to the newer addition of Bicycle radio-conjugates (BRCs). I look forward to working alongside the team to help patients in need of new treatment options, by moving forward the entire pipeline and expanding the potential applications of the Bicycle platform across oncology and beyond."

Dr. Lee added, "On behalf of our Board and the entire team at Bicycle, I want to thank Lee Kalowski for his contributions to the company. Lee, who served as Bicycle’s Chief Financial Officer since 2017, was instrumental in his work leading the company through its IPO and subsequent fundraisings, putting Bicycle in a strong financial position for our future."

Ms. Young has more than 20 years of experience in the healthcare and biotech industry. Prior to joining Graphite Bio as Chief Financial Officer in 2022, she served as senior biotech analyst and head of research at Cantor Fitzgerald, managing the equity research department covering small-cap, mid-cap and large-cap biotechnology companies. Before joining Cantor Fitzgerald in 2018, Ms. Young held senior biotech analyst positions at Credit Suisse and Deutsche Bank. Earlier in her career, she was a research policy analyst and president at Marwood Group, providing healthcare-focused advisory services to institutional investors. She began her career at J.P. Morgan in the investment banking and asset management divisions. She earned a B.A. in economics and Spanish from Duke University.

In addition, Bicycle announced the promotion of Travis Thompson, Senior Vice President, Finance, to Senior Vice President, Chief Accounting Officer. Mr. Thompson will work alongside Ms. Young, overseeing the company’s financial and accounting operations.

On June 23, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported the six abstracts accepted for oral and poster presentation at the upcoming Society for Nuclear Medicine & Molecular Imaging (SNMMI) 2023 Annual Meeting, which will be held in Chicago, June 24-27, 2023 (Press release, Actinium Pharmaceuticals, JUN 23, 2023, View Source [SID1234632870]). These abstracts exhibit the breadth of Actinium’s technological and clinical endeavors over the past year that are now culminating in targeted radiotherapies that meaningfully improve the outcomes of cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the SNMMI oral presentations:

Presentation Title: Machine learning applications to optimize dosimetric imaging of I131-apamistamab for bone marrow conditioning in relapsed/refractory acute myeloid leukemia (R/R AML)
Session: New Developments in Radiopharmaceutical Therapy
Date and Time: June 25, 5:00pm – 6:15pm CT

Presentation Title: Individualized dosing for high-dose targeted radiation of hematopoietic cells with Iomab-B (I131-apamistamab) prior to HCT in relapsed/refractory acute myeloid leukemia (R/R AML): Safety and efficacy results from the pivotal phase 3 SIERRA trial
Session: Hematologic Malignancies
Date and Time: June 26, 12:45 PM – 2:00 PM CT

Presentation Title: Administration and radiation safety of high-dose Iomab-B (I131-apamistamab) demonstrated in multiple clinical settings: Experience from the large multicenter phase 3 SIERRA trial for targeted conditioning of patients with relapsed/refractory AML
Session: Hematologic Malignancies
Date and Time: June 26, 12:45 PM – 2:00 PM CT

Details of the SNMMI poster presentations:

All posters will be accessible for viewing for the entirety of the conference. The general session is Science Pavilion – Meet the Authors Session: June 26, 5:15pm – 6:15pm CT

Abstract Title: Organ-specific dosimetry to estimate potential toxicity thresholds of Actimab-A (lintuzumab-Ac225) used in combination with venetoclax in relapsed/refractory AML
Track: Molecular Targeting Probes
Date and Time: June 25, 6:30 – 8:30 pm CT

Abstract Title: Relative biological effectiveness of antibody radioconjugates (ARCs): In vitro dosimetric evaluation to streamline pre-clinical decision-making
Track: Oncology, Basic and Translational
Date and Time: June 27, 12:30 – 2:00 pm CT

Abstract Title: Streamlining personalized dosimetry for I131-apamistamab using a Co-57 sheet source to circumvent the need for radionuclide-specific attenuation correction
Track: Molecular Targeting Probes-Radioactive & Nonradioactive
Date and Time: June 27, 12:30 – 2:00 pm CT

On June 22, 2023 Kanvas Biosciences, the leader in microbiome mapping technology, reported a $12M Pre-Series A funding round (Press release, Kanvas Bioscience, JUN 22, 2023, View Source [SID1234644493]). The investment will be used to further advance the company’s proprietary platform technology, which promises to revolutionize drug development for microbiome-associated diseases. The round was led by DCVC with participation from Lions Capital LLC, Cooke LLC, Uncommon Denominator, and Triple Impact Capital. As part of the investment round, Jason Pontin, partner at DCVC, will join the company’s board of directors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The interactions between the microbiome and its host are critical to human health. The current gold standard for analyzing these interactions is to extract a sample, blend it, and sequence the genetic material in the sample. This strategy enables broad inferences about the composition of the sample, but little more, as information regarding biospatial localization and cellular function is lost in the process.To overcome this challenge, Kanvas has developed a revolutionary technology platform that enables highly multiplexed spatial profiling of microbial species. The platform not only determines the identity and function of these microbes, but also maps the host’s corresponding local response – all executed within a single, comprehensive assay.

With Kanvas’ proprietary technology, based on research first published in Nature by the company’s founders, researchers can profile both the microbiome and the host cells with sub-cellular resolution to provide critical context and unparalleled insight into complex host-microbe interactions. This platform can be applied to the discovery and development of novel, live biotherapeutic products, the identification of disease-associated microbes for diagnostics, and leveraging the microbiome to improve therapeutic responses.

"Our technology takes the gastrointestinal tract and the microbiome from black box to transparent and measurable terrain," says Kanvas Biosciences co-founder and CEO Matthew Cheng, MD. "We are thrilled to drive forward the development of life-saving treatments for some of the world’s most common conditions." While the microbiome has long been associated with inflammatory bowel disease and colon cancer, emerging data indicate its intimate connection to a range of conditions beyond the gastrointestinal tract, including cardiovascular disease, metabolic disorders, and response to cancer immunotherapy treatments.

The raised capital will be used towards expanding Kanvas’ proprietary single-cell spatial transcriptomics platform and launching biological and R&D discovery platforms. To this end, Kanvas has already established partnerships with leading biotechnology and pharmaceutical companies.

"This breakthrough technology empowers researchers to explore microbial communities in unprecedented ways, with profound implications for the health and biomedical industries. It fundamentally transforms our understanding of the human microbiome, allowing us to consider it as a distinct and druggable organ, opening uncharted territories in medicine," said Jason Pontin of DCVC.

On June 22, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma (GBM) (Press release, Erasca, JUN 22, 2023, View Source [SID1234639353]). ERAS-801 is an orally bioavailable, small molecule EGFR inhibitor that exhibited substantial central nervous system (CNS) penetration in preclinical animal studies.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Per FDA regulations, ODD is granted by the FDA to investigational therapies addressing rare medical diseases or conditions affecting less than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and the potential for seven years of post-approval marketing exclusivity.

"GBM is an aggressive malignancy afflicting approximately 37,000 patients annually in the United States and Europe. Currently approved EGFR inhibitors are limited by insufficient CNS penetration to treat GBM and minimal activity against GBM-specific EGFR amplifications, mutations, and other molecular alterations, which contribute to high rates of relapse and a five-year survival rate below 10%," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Receiving ODD recognizes both the importance of innovation for patients with GBM and the therapeutic potential of ERAS-801 to provide a targeted treatment option for these patients, who have a poor prognosis. This ODD follows the earlier Fast Track Designation granted to ERAS-801 by the FDA and underscores the urgency of finding new treatments for this patient population. The broad activity against both oncogenic and wildtype EGFR, high CNS penetration, and demonstrated ability to improve outcomes in over 90% of diverse EGFR-driven patient-derived glioma models support the potential for ERAS-801 to overcome current challenges with existing therapies. We anticipate reporting initial monotherapy data for ERAS-801 from the Phase 1 THUNDERBBOLT-1 trial in patients with recurrent GBM in the second half of 2023."

ERAS-801 was designed and developed by a renowned team of cancer researchers—Michael Jung, Ph.D., Timothy Cloughesy, M.D., and David Nathanson, Ph.D.

About ERAS-801
ERAS-801 is a highly potent, selective, reversible, and orally bioavailable small molecule EGFR inhibitor with significantly enhanced CNS penetration. In animal models, ERAS-801 had a brain-to-plasma partition coefficient, Kp, of 3.7 and a corresponding unbound partition coefficient, Kp,uu, of 1.2, which was up to four times higher than approved EGFR inhibitors, suggesting that approximately 100% of the free drug in plasma is able to cross the blood-brain barrier (BBB). At clinically relevant exposures across 30 patient-derived GBM models that were intended to represent the heterogeneity of GBM, ERAS-801 demonstrated a survival benefit in 13 out of 14 (93%) EGFR mutant and/or amplified models and had statistically significantly higher brain penetrance and prolonged survival compared to approved EGFR tyrosine kinase inhibitors, including osimertinib, lapatinib, and erlotinib. ERAS-801 is currently being evaluated as a monotherapy in THUNDERBBOLT-1, an ongoing Phase 1 trial in patients with recurrent GBM (rGBM). In April 2023, the FDA granted Fast Track Designation (FTD) to ERAS-801 for the treatment of adult patients with GBM with EGFR gene alterations. In June 2023, the FDA granted ODD to ERAS-801 for the treatment of malignant glioma, which includes glioblastoma.

About THUNDERBBOLT-1
THUNDERBBOLT-1 is evaluating the safety, tolerability, and preliminary efficacy of ERAS-801 as a monotherapy in patients with rGBM. The dose escalation portion will determine the recommended dose, which will then be used during the dose expansion portion to further evaluate the efficacy and safety of ERAS-801. Future sub-studies of THUNDERBBOLT-1 may potentially explore ERAS-801 in combination with other agents and in broader patient types. Initial Phase 1 data from THUNDERBBOLT-1 are anticipated in the second half of 2023.